The training will take place next 16-17 May 2017 in Barcelona and it will provide an insight in the challenging environment of EU regulatory legislation.
The event is organized by Life Science Academy and the lecturers are Lidia Cánovas, General Manager in Regulatory Affairs at Asphalion, and Remco Munnik, Regulatory Information Director at Asphalion. Our experts will run the presentations and provide practical advice for future work.
The program encompasses the understanding of the new regulatory procedures such us Transparency policy, EudraCT, adaptive licensing, ISO IDMP and Falsified Medicine Directive. Electronic submission through the different platforms will also be covered as well as advanced RA on specific type of products. Besides, managing strategies and procedure guidelines will be provided. A pragmatic point of view will be given through business cases and questions from the audience.
The course is aimed at specialist from pharmaceutical companies and CRO like regulatory affairs officers or managers, technicians, quality managers, development pharmacists, pharmacovigilance professionals or project managers, willing to broaden RA knowledge.
At the end of the training, participants will be able to understand the complex legislations and requirements and increase their awareness of the latest developments in order to ensure compliance in future.
For more information, please contact us at [email protected].
